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IRCT20210805052086N1 IRCT 2021-11-04 Kermanshah University of Medical Sciences Comparative study of the effect of Anaheal and oral Corticosteroids in reducing Edema and Ecchymosis after Rhinoplasty Comparative study of the effect of Anaheal and oral Corticosteroids in reducing Edema and Ecchymosis after Rhinoplasty. 2021-10-23 anticipated 120 Complete https://irct.ir/trial/58120 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples studied in this study will be done using random assignment of patient to the study groups. In the study, samples are assigned to the two groups by permutation block random sampling. Thus, the study will continue until the number of samples is completed. In the method, we first determine a sample size of the general sample and then randomly assign a set of them to one group and the rest to another group. to the perform this randomization method, we proceed as follow: 1- The total sample size and the sample size ratio in the groups are determined. in the study, the number of samples will be 120 people with a 1:1 allocation. 2- The number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. 3- For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block of 0.5. block 0-4 can be used for the first group and block 5-9 for the second treatment. 4- Based on the selected numbers from the table of random numbers and determination of blocks, it is clear in which group each person who enters the study will be placed, Blinding description: Patients are treated with medication packages pre-determined by the study supervisor. drug packages are a quite similar in shape and patients are not aware of the contents of the packages. The cards with the number 1 and 2 on them and the secret codes related to the drug are in the packages and every patient who enters the study and receives the medicine dies not know the type of medicine. In addition, collecting information, assessing patients and completing forms is done by the project manager and his assistant, who are not aware of the contents of the packages; Therefore, the study is double-blind and the contents of the two drug groups are not clear from the stage of the patient entering the study until the end of the study. 1-2 Rhinoplasty. Intervention 1: Intervention group: Take Anaheal 500mg oral tablets twice a day; morning and night, for 7 days. Intervention 2: Intervention group: Take prednisolone 5 mg oral tablets twice a day; morning and night, for 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Farzad Rezai
School of Dentistry, Shura St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3722 7151 Far_rezaei@kums.ac.ir Kermanshah University of Medical Sciences scientific Yavar Sayadi
Unit 1, 10th Floor, E11 Block, Shaghayegh Blvd., Pardis Town
Kermanshah Iran (Islamic Republic of) 6717880167 0098 83 6523190 yavarsayadi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) All clients requesting rhinoplasty surgery no limit no limit Both Underlying diseases such as hemophilia, asthma, and liver and kidney failure Taking oral or injectable drugs from other medical centers History of allergy to corticosteroid Z41 Encounter for procedures for purposes other than remedying health state Treatment - Drugs Treatment - Drugs Intervention group: Take Anaheal 500mg oral tablets twice a day; morning and night, for 7 days Intervention group: Take prednisolone 5 mg oral tablets twice a day; morning and night, for 7 days The rate of edema. Timepoint: Third, fifth and seventh day. Method of measurement: 4-point scale. The rate of ecchymosis. Timepoint: Third, fifth and seventh day. Method of measurement: 4-point scale. Deputy of Research and Technology Approved 2021-10-19 Ethics committee of Kermanshah University of Medical Sciences Shahid Beheshti Boulevard, Building No. 2 of Medical Sciences, Research and Technology Department Kermanshah Kermanshah Iran (Islamic Republic of)